IN2Pharma
Consultancy and outsourcing firm providing regulatory, quality assurance, pharmacovigilance, medical support and compliance services for pharmaceutical, medical device, cosmetic and food supplement companies, with a focus on clients in the Benelux region.
Industries
Nr. of Employees
small (1-50)
Products
Medical writing & training
IN2Pharma provides a full range of medical support including writing or reviewing scientific and medical reports, and creating and presenting medical training courses.
Publicity and Compliance
Professional services supporting the compliance of promotional materials, advertising activities, and transparency reporting for medicinal and healthcare products in Belgium, the Netherlands, and Luxembourg.
Regulatory Affairs
Support services in obtaining and maintaining Marketing Authorizations for medicinal products, medical devices, cosmetics and food supplements.
Quality Assurance
Specialized consulting services in good distribution practices (GDP), Good Manufacturing Practices (GMP) including importation and batch release.
Vigilance
Vigilance services helping companies comply with legal obligations for pharmacovigilance, materiovigilance, cosmetovigilance and food safety plans.
Keuringsraad KOAGKAG Rates Advice
Consultation service for advice regarding promotional material and claims for medicinal products, medical devices, and health products, categorized into simple and complex advice.
Medical writing & training
IN2Pharma provides a full range of medical support including writing or reviewing scientific and medical reports, and creating and presenting medical training courses.
Publicity and Compliance
Professional services supporting the compliance of promotional materials, advertising activities, and transparency reporting for medicinal and healthcare products in Belgium, the Netherlands, and Luxembourg.
Regulatory Affairs
Support services in obtaining and maintaining Marketing Authorizations for medicinal products, medical devices, cosmetics and food supplements.
Quality Assurance
Specialized consulting services in good distribution practices (GDP), Good Manufacturing Practices (GMP) including importation and batch release.
Vigilance
Vigilance services helping companies comply with legal obligations for pharmacovigilance, materiovigilance, cosmetovigilance and food safety plans.
Keuringsraad KOAGKAG Rates Advice
Consultation service for advice regarding promotional material and claims for medicinal products, medical devices, and health products, categorized into simple and complex advice.
Services
Assume regulatory, quality assurance, pharmacovigilance and medical responsibilities for client organisations in the Benelux region, including representation to authorities where required.
Assistance with preparation and maintenance of marketing authorisation dossiers and interactions with national and regional competent authorities.
Pharmacovigilance, materiovigilance, cosmetovigilance and food supplement safety planning services, including adverse event reporting and compliance with reporting obligations.
Quality assurance support including GDP and GMP compliance, importation activities and batch release services.
Preparation and review of scientific and medical documents and the development and delivery of medical training courses.
Assessment and support to ensure promotional materials and sponsored activities comply with applicable regulations.
Assume regulatory, quality assurance, pharmacovigilance and medical responsibilities for client organisations in the Benelux region, including representation to authorities where required.
Assistance with preparation and maintenance of marketing authorisation dossiers and interactions with national and regional competent authorities.
Pharmacovigilance, materiovigilance, cosmetovigilance and food supplement safety planning services, including adverse event reporting and compliance with reporting obligations.
Quality assurance support including GDP and GMP compliance, importation activities and batch release services.
Preparation and review of scientific and medical documents and the development and delivery of medical training courses.
Assessment and support to ensure promotional materials and sponsored activities comply with applicable regulations.
Expertise Areas
- Regulatory affairs
- Pharmacovigilance and vigilance
- Quality assurance (GMP/GDP)
- Medical writing and training
Key Technologies
- Pharmacovigilance/adverse event reporting systems
- GMP compliance processes
- GDP compliance processes
- Regulatory submission workflows
News & Updates
Summary of additional guidance from a national body on the use of 'absolute' claims for food supplements and a vitamins/minerals table to avoid misleading claims.
Overview of recent updates to the Dutch Medicines Act covering the Medicines Evaluation Board composition and manufacturer licensing requirements.
Summary of recent changes to Good Pharmacovigilance Practices (GVP) guidance including new guidance on masking personal data in ICSRs.
Article describing suspension of a law provision related to medicine unavailability and implications for wholesalers and distribution.
Summary of additional guidance from a national body on the use of 'absolute' claims for food supplements and a vitamins/minerals table to avoid misleading claims.
Overview of recent updates to the Dutch Medicines Act covering the Medicines Evaluation Board composition and manufacturer licensing requirements.
Summary of recent changes to Good Pharmacovigilance Practices (GVP) guidance including new guidance on masking personal data in ICSRs.
Article describing suspension of a law provision related to medicine unavailability and implications for wholesalers and distribution.